from the urls-we-dig-up dept

If we really wanted to tackle drug problems, we might want to try alternatives to alcohol that might have antidotes. However, we've tried to outlaw alcohol before, and it didn't turn out too well. Marijuana is beginning to become slightly less illegal (not on the federal level), and some studies show it's not nearly as harmful a drug as some folks believe it is. Put down your bongs, stop giggling at that cartoon you've been watching all day, and check out some of these links on the effects of marijuana.

from the get-those-lawyers-ready dept

If you program a bot to autonomously buy things online, and some of those things turn out to be illegal, who's liable? We may be about to have the first such test case in Switzerland, after an autonomous buying bot was "seized" by law enforcement.

Two years ago, we wrote about the coming legal questions concerning liability and autonomous vehicles. Those vehicles are going to have some accidents (though, likely fewer than human driven cars) and then there are all sorts of questions about who is liable. Or what if they speed? Who gets the ticket? There are a lot of legal questions raised by autonomous vehicles. But, of course, it's not just autonomous vehicles raising these questions. With high-frequency trading taking over Wall Street, who is responsible if an algorithm goes haywire?

This question was raised in a slightly different context last month when some London-based Swiss artists, !Mediengruppe Bitnik, presented an exhibition in Zurich of The Darknet: From Memes to Onionland. Specifically, they had programmed a bot with some Bitcoin to randomly buy $100 worth of things each week via a darknet market, like Silk Road (in this case, it was actually Agora). The artists' focus was more about the nature of dark markets, and whether or not it makes sense to make them illegal:

The pair see parallels between copyright law and drug laws: “You can enforce laws, but what does that mean for society? Trading is something people have always done without regulation, but today it is regulated,” says ays Weiskopff.

“There have always been darkmarkets in cities, online or offline. These questions need to be explored. But what systems do we have to explore them in? Post Snowden, space for free-thinking online has become limited, and offline is not a lot better.”

But the effort also had some interesting findings, including that the dark markets were fairly reliable:

“The markets copied procedures from Amazon and eBay – their rating and feedback system is so interesting,” adds Smojlo. “With such simple tools you can gain trust. The service level was impressive – we had 12 items and everything arrived.”

“There has been no scam, no rip-off, nothing,” says Weiskopff. “One guy could not deliver a handbag the bot ordered, but he then returned the bitcoins to us.”

But, still, the much more interesting question is about liability in this situation. The Guardian reporter who wrote about this in December spoke to Swiss law enforcement, who noted that the situation was "unusual":

A spokesman for the National Crime Agency, which incorporates the National Cyber Crime Unit, was less philosophical, acknowledging that the question of criminal culpability in the case of a randomised software agent making a purchase of an illegal drug was “very unusual”.

“If the purchase is made in Switzerland, then it’s of course potentially subject to Swiss law, on which we couldn’t comment,” said the NCA. “In the UK, it’s obviously illegal to purchase a prohibited drug (such as ecstasy), but any criminal liability would need to assessed on a case-by-case basis.”

On the morning of January 12, the day after the three-month exhibition was closed, the public prosecutor's office of St. Gallen seized and sealed our work. It seems, the purpose of the confiscation is to impede an endangerment of third parties through the drugs exhibited by destroying them. This is what we know at present. We believe that the confiscation is an unjustified intervention into freedom of art. We'd also like to thank Kunst Halle St. Gallen for their ongoing support and the wonderful collaboration. Furthermore, we are convinced, that it is an objective of art to shed light on the fringes of society and to pose fundamental contemporary questions.

It appears possible that, in this case, law enforcement was just looking to seize and destroy the contraband products that were purchased by the bot, and may not then seek further prosecution, but it still does raise some interesting questions. I'm not sure I buy the "unjustified intervention in the freedom of art" argument (though that reminds me of another, unrelated story, of former MIT lecturer Joseph Gibbons, who was recently arrested for robbing banks, but who is arguing that it was all part of an "art project").

Still, these legal questions are not going away and are only going to become more and more pressing as more and more autonomous systems start popping up in different areas of our lives. The number of different court battles, jurisdictional arguments and fights over who's really liable are likely to be very, very messy -- but absolutely fascinating.

from the urls-we-dig-up dept

If you haven't heard about MSRA (methicillin-resistant Staphylococcus aureus) yet, it's a strain of bacteria that can't be killed by common antibiotic drugs. Antibiotic drugs have been over-used or mis-used in various situations, and bacteria are evolving resistance to the drugs we've been using for decades. Without antibiotics, healthcare would be thrust back into the dark ages. No surgeries could be done safely without antibiotics. Very common infections might kill off people regularly, instead of being the mild inconvenience that they are today. Check out these links for more info on superbugs and how we can deal with them.

from the the-evilness-of-drug-companies dept

The astoundingly wonderful radio program/podcast Radiolab just recently had an episode called "Worth" -- which included a few different stories trying to establish how much something is truly "worth." The first story in the collection talked about how much extra time in life is worth, as part of a discussion on whether or not it's reasonable for certain drugs to be priced insanely high. It was an interesting discussion, mostly revolving around the question of whether it's "worth" paying tends of thousands of dollars for a drug treatment that might only extend your life a few weeks. There is just a brief discussion about whether or not it's appropriate for pharmaceutical companies to charge the rates that they do -- with the Radiolab team unfortunately accepting the tired (and incredibly misleading) claim from a drug company that because drug research includes so many failures, it needs to charge these ridiculous high rates to make up for all the failures.

This is misleading in all sorts of ways, though that will need to be the subject of another post at another time. My biggest complaint, after the story was over, was that it failed in economics 101. It stuck with the premise that there was a quantifiable single amount that something was "worth" -- and that price is a reflection of that. This is something that many people tend to feel, instinctively, but it's not accurate. The value of something is different to different people and depends on many factors. The price of something may be quite different than the value -- again, something we've been highlighting for years.

Here's the key bit: the price of something is driven by supply and demand. When you -- as the program did -- look at price solely based on "value" you're only looking at the demand side of the equation, and not the supply. And that's where things get extra tricky in pharmaceutical pricing -- because the supply side is massively distorted through patents, which enable drug companies to artificially limit the supply, driving up prices to insane levels. In a normal, functioning society, we might recognize that this is a problem. Deriving pricing for healthcare solely based on demand is ludicrous, and shows a society with very short-term thinking. It prioritizes short-term narrow profits of drug companies over long-term contributions from a more healthy populace.

But this is the way of our pharmaceutical industry today. And these distortions have become something of, well, a drug to the pharma industry. They've become so fat and happy based on the monopoly rents of patents artificially limiting supply, that they can't fathom how to survive without such rents. That crutch has resulted in big pharma running into some serious problems lately -- because they haven't been discovering many really valuable new drugs lately. At the same time, many of their old drugs have seen their patents start to expire.

In response, pharmaceutical companies have been pulling out all sorts of tricks to try to extend the monopoly rents (rather than actually improving people's health or their own business model). For a while, we were discussing "pay for delay" schemes, in which big pharmaceutical companies would sue small generic drug makers... and then "settle" by paying those generic companies a bunch of cash not to compete with generic drugs for some time. That practice recently became harder after the Supreme Court said that the FTC can go after such practices as a form of antitrust enforcement.

But that's not the only game that big pharmaceutical firms have been playing. A recent lawsuit filed by New York against Forest Labs and its parent company Actavis revealed that the company was trying to force Alzheimer's patients onto a new drug, and away from one that they had been using. The only real difference in the two drugs: the length of the patent protection. Basically, the company was trying to force patients onto a drug that wasn't close to becoming available in generic forms, which would make it much, much cheaper. From the lawsuit:

This case is brought to prevent Defendants from illegally maintaining their
monopoly position and inflating their profits at the expense of patients suffering from
Alzheimer's disease. The manipulative tactic that the Defendants seek to employ here is what
some in the industry, including Defendants' own CEO, have called a "forced Switch." In a
forced switch, a pharmaceutical company that sells a drug facing imminent generic competition
withdraws its drug from the market, forcing patients to switch to a different form of the drug
with patents that expire later. The switch has the effect of impeding the entry of lower-cost
generic drugs. A physician recently complained to Defendants, aptly describing their
contemplated action as "immoral and unethical." It is also illegal.

Defendants sell a blockbuster drug to treat Alzheimer's disease, called Namenda.
Namenda is Forest's top selling drug, and is protected by patent and regulatory exclusivities that
prevent generic versions from entering the market until July 2015. But rather than allowing
patients with Alzheimer's to continue to take Namenda and switch to the less expensive generic
version when it becomes available, as contemplated by federal and state drug laws, Forest
instead hatched a scheme that interferes with patients' ability to make this switch.

Defendants' strategy is to discontinue or severely restrict patient access to its
original, immediate-release version of Namenda, known as Namenda IR, prior to generic entry in
order to force patients to switch to Forest's newer, virtually identical, extended-release version of
Namenda, called Namenda XR. Because Namenda XR is protected by patents for many years
longer than the original Namenda IR, Defendants' goal is to use the "forced switch" to reap
several more years of monopoly profits than they would have earned otherwise. Under generic
substitution laws, a pharmacist will not be able to substitute lower-priced generic Namenda IR
(known as memantine) for Namenda XR. As a result, once patients have switched to
Namenda XR, it will destroy the market for the generic form of Namenda IR because of the
dramatically increased burden, cost, and time needed to arrange for patients who have been
switched to Namenda XR to switch back to the original version.

Thankfully, a few weeks ago, an initial ruling in the case found that Actavis could not move forward with these "forced switch" plans and needed to continue making the original drug, Namenda IR, available. The full court ruling [pdf] is fairly detailed in how Actavis has a monopoly on the market for memantine and is abusing it in anti-competitive ways. The court notes that merely having a patent isn't necessarily proof of a monopoly -- but in this case, Actavis absolutely does have a monopoly. Further, it notes that just because you have a monopoly, it doesn't mean you're abusing it. But... Actavis does appear to be abusing its monopoly position. It didn't help that Forest Labs CEO, Brent Saunders (recently moved up to Actavis CEO as well), was pretty open about this:

Saunders stated, contemporaneously with the adoption
of the hard switch by Forest, that the purpose of the switch was
anticompetitive: to put barriers obstacles in the path of
producers of generic memantine and thereby protect Namenda’s
revenues from a precipitous decline following generic entry.... He further stated: “if we do the hard switch and
we’ve converted patients and caregivers to once-a-day therapy
versus twice a day, it’s very difficult for the generics then to
reverse-commute back, at least with the existing
[prescriptions]. They don’t have the sales force, they don’t
have the capabilities to go do that. It doesn’t mean that it can’t happen, it just becomes very difficult. It is an obstacle
that will allow us to, I think, again go into to a slow decline
versus a complete cliff.”).

Of course, this particular practice, of trying to force people to avoid generic competition is increasingly widespread. As I was finishing up this post, I came across a similar, if equally disturbing, story about Pfizer directly threatening doctors should they decide to prescribe generic versions of pregabalin, an anti-epilepsy drug, that will also go off patent in 2015. But here's the tricky part: Pfizer holds a different patent on the same drug if it's used to treat pain (rather than epilepsy). Pfizer is claiming that prescribing the generic version for pain use would lead to serious problems -- even though it's the same damn drug.

You will see that, whilst the basic patent for pregabalin has expired and regulatory data protection for Lyrica expired in July 2014, Pfizer has a second medical use patent protecting pregabalin's use in pain which extends to July 2017. Pfizer conducted further research and development on pregabalin leading to the invention of its use in pain and hence was granted a second medical use patent for this indication. This patent does not extend to pregabalin's other indications for generalized anxiety disorder (GAD) or epilepsy.

As a result of the pain patent, we expect that generic manufacturers will only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder and not for pain, whilst Pfizer's pain patent is in place. Generic pregabalin products therefore are expected not to have the relevant information regarding the use of the product in pain in the PIL (Patient Information Leaflet) and SmPC (Summary of Product Characteristics). In other words, the generic pregabalin products are expected to carry so-called "skinny labels" and will not be licensed for use in pain. In the circumstances described above, Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the UK would infringe Pfizer's patent rights. This would not be the case with supply or dispensing of generic pregabalin for the non-pain indications, but we believe it is incumbent on those involved to ensure that skinny labeled generic products are not dispensed and used for pain.

In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indication. Without information, guidance and practical solutions from the authorities, Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act. This runs contrary to the government's established policy of rewarding additional research by the granting of a second medical use patent.

As Cory Doctorow notes in the article above, Pfizer here seems to be trying to take its own "stupid problem" and make it everyone else's stupid problem:

Weirder still is that Pfizer wants to make their stupid problem into everyone else's stupid problem. The fact that it's hard to enforce this kind of secondary patent is Pfizer's business, not doctors'. Doctors' duty is to science and health, not Pfizer's profit-margins. Scientifically, there's no difference between the two compounds. Doctors who prescribe generics leave their patients (or possibly the NHS) with more money to pursue their other health goals.

If your dumb government monopoly is hard to enforce, maybe you shouldn't be banking on it. But in the world of corporatist sociopathy, where externalising your costs on others isn't just a good idea, it's your fiduciary duty to your shareholders, Pfizer's actions are practically inevitable.

And this brings us back to the problem discussed at the very top of this article. The entire pharmaceutical industry has built its business around the idea of artificially reducing supply -- rather than about providing more benefit (health). That's really screwed up. A good business focuses on expanding the benefit to users, not limiting it to charge more. Our patent policy has created incentives for exactly the opposite -- and that is having a massive impact on the health and well-being of people around the globe.

"You say there's not anything illegal in it. Do you mind if I search it today to make sure?" the officer asked.

Lisa responded, "I'd have to talk to my husband."

[...]

The agent continued, "I am asking you for permission to search your vehicle today -- and you are well within your rights to say no and you can say yes. It's totally up to you as to whether you want to show cooperation or not."

[...]

"You have to either give me a yes or no," he continued. "I do need an answer so I can figure out whether I need a dog to go around it or not."

Because the agent was unable to obtain consent from the couple, he decided to ask a dog. A drug-sniffing dog was brought in to examine the vehicle and, go figure, it alerted near the driver's side window (after ignoring the open passenger's side window). Finally having obtained "permission" for a warrantless search, the two agents went to work. An hour later -- and having disassembled the dashboard of the couple's new car -- they were unable to recover anything incriminating. But hey, no one's rights were violated because the drug dog told officers the car contained drugs, even though it didn't.

It also didn't contain any cash, which one agent told the Ronnie Hankins was far more likely to be hidden somewhere in the vehicle.

[W]hen Ronnie insisted there were no drugs, the agent confided he wasn't really expecting any.

"Well, I'll be honest with you, with you going this direction, I wouldn't think you'd have drugs in the car -- you would have a large amount of money," he said.

While drugs generally come from Mexico on the eastbound side of Interstate 40 and the drug money goes back on the westbound side, the investigation discovered police making 10 times as many stops on the so-called "money side."

The frustrated officers finally let the Hankins go, but not before making a last-ditch effort to redeem their futile efforts. The police report claims the interdiction agents found "marijuana debris" or "shake" on the floorboards of the vehicle. The Hankins claim the only thing on the floorboards was grass from the cemetery where Ronnie Hankins' grandfather was buried. Whether it was "grass" or grass, neither of the Hankins were charged or cited.

Tennessee's asset forfeiture laws are far worse than those in many states. 100% of the proceeds of any seizures go to the department that performed it. Legislative attempts to overhaul these laws have been mostly fruitless. A bill introduced in early 2013 aimed to eliminate this abuse by making seizures contingent on convictions. By the time the House and Senate had amended the bill, the only net gain was the prohibition of ex parte hearings. If Tennesee interdiction officers seize your money or other property, they now (the law went into effect at the beginning of this year) have to give you a date when you can show up and defend "forfeited" property from the accusations of law enforcement -- something of limited utility considering these officers tend to prey on drivers with out-of-state plates. Depending on what has been seized, it may be cheaper to allow the state to claim its ill-gotten goods rather than spending even more money to participate in a largely ceremonial process that often results in the state paying out only pennies on the dollar.

from the more-drug-warring dept

Another tool supposedly "crucial" to the War on Terror is just another lowly footsoldier in the War on Drugs. Some long-delayed reports on Section 213 "sneak and peek" warrants have finally been released by the US government, providing more detail on the constantly-expanding use of delayed-notification warrants by the FBI.

While not scheduled to sunset, the USA Patriot Act's delayed notice provision, Section 213, has been the subject of criticism and various legislative proposals. The FBI believes that Section 213 is an invaluable tool in the war on terror and our efforts to combat serious criminal conduct. It is important to note that delayed notice warrants were not created by the USA Patriot Act. Rather, the Act simply codified a common law practice recognized by courts across the country and created a uniform nationwide standard for the issuance of those warrants…

Delayed notice search warrants provide a crucial option to law enforcement and can only be issued if a federal judge finds that one of five tailored circumstances exists. The FBI has requested this authority in several cases. In most instances, the FBI seeks delayed notice when contemporaneous notice would reasonably be expected to cause serious jeopardy to an ongoing investigation.

Apparently, the department sought and received the authority to delay notice 108 times between April 2003 and January 2005, a period of approximately 22 months. By contrast, it sought and received this authority 47 times between November 2001, when the PATRIOT Act was enacted, and April 2003, a period of about 17 months. The 5-month difference in timeframe aside, these numbers clearly reveal a substantial increase in use.

From 47 times in 17 months to over 30 times a day over the last ten years. This is another limited-use, for-emergency-use-only tool that has been converted into a workhouse by law enforcement. To keep it from being killed off, FBI Director Robert Mueller cited terrorism and investigations being placed in "serious jeopardy," but in reality, it's still all about drugs, drugs and more drugs.

Out of the 3,970 total requests from October 1, 2009 to September 30, 2010, 3,034 were for narcotics cases and only 37 for terrorism cases (about .9%). Since then, the numbers get worse. The 2011 report reveals a total of 6,775 requests. 5,093 were used for drugs, while only 31 (or .5%) were used for terrorism cases. The 2012 report follows a similar pattern: Only .6%, or 58 requests, dealt with terrorism cases. The 2013 report confirms the incredibly low numbers. Out of 11,129 reports only 51, or .5%, of requests were used for terrorism.

Additionally, only 11 requests were rejected and the average delay was over 60 days. The longest recorded in 2013 was well over a year -- 546 days.

This was supposed to be an option of last resort -- something deployed when it was too dangerous to do otherwise. But it never was anything more than a way to skirt the Fourth Amendment for maximum FBI efficiency. Even in its early days -- not far removed from the horror of the 9/11 attacks -- the FBI was using delayed notice warrants to conduct routine investigations.

It would astound most Americans that government agents could enter their homes while they are asleep or their places of business while they are away and carry out a secret search or seizure and not tell them until weeks or months later. It would especially astound them that this authority is available for all Federal offenses, ranging from weapons of mass destruction investigations to student loan cases. That is what Section 213 of the PATRIOT Act authorizes. Indeed, the Justice Department has admitted that it has used Section 213 sneak and peek authority in nonviolent cases having nothing to do with terrorism. These include, according to the Justice Department's October 24, 2003 letter to Senator Stevens, an investigation of judicial corruption, where agents carried out a sneak and peek search of a judge's chambers, a fraudulent checks case, and a health care fraud investigation, which involved a sneak and peek of a home nursing care business.

So, the DOJ requests an inch, takes several miles, and searches citizens' homes and places of business several thousand times a year -- all without feeling compelled to inform its targets. The justifications the FBI offers (and has offered for years) are false. Are we actually supposed to believe the danger posed to investigating officers has increased at the same rate as the deployment of "sneak and peek" warrants? The defenders of this program can't expect anyone to believe anything that ridiculous. And yet, it continues -- not just unabated, but with steady increases.

Section 213 is just another way for the DOJ to keep the pesky public from impeding its forward progress. Anything hinting of rights or civil liberties is generally viewed as a loophole for criminals to exploit. This is more of the same. It's easier to execute search warrants when you don't have to bother serving them first.

from the regulatory-loophole dept

Last year, we wrote about a disturbing abuse of the orphan drug system in the US, which is designed to encourage the development of treatments for rare diseases, but which in practice can allow companies to increase prices hugely. Here's another example, reported by Adam Feuerstein in The Street, that is in some ways even worse. It concerns a company called Catalyst Pharmaceutical Partners, which has just reported what seems like good news for those suffering from Lambert-Eaton Myasthenic Syndrome (LEMS), a progressive, muscle-weakening disease. Catalyst has announced positive results from a final phase trial of a drug called "Firdapse." As The Street article reports, analysts believe that once approved by the US Food and Drug Administration, Firdapse could cost between $60,000 and $80,000 per year if it is designated an orphan drug, which brings with it seven years of marketing exclusivity. That might seem the going rate for new drugs, but there's a nasty twist in this tale, as Feuerstein notes:

Firdapse is not a new treatment for LEMS. The active ingredient in Firdapse is a compound known as 3,4-Dap, which has been available in the U.S. for more than 20 years. Doctors treating the small numbers of LEMS patients in the U.S. can obtain inexpensive 3,4-Dap from compounding pharmacies. It's even given away for free to doctors and patients by a tiny New Jersey drug maker, Jacobus Pharmaceuticals.

That means that Catalyst took no risks with Firdapse. Indeed, it didn't really do anything at all, as Feuerstein explains:

The company did no development work, made no effort to improve the drug's efficacy, safety or convenience for patients.

And yet despite that fact, it stands to profit handsomely:

For the zero work done by Catalyst, LEMS patients and their insurance companies will be paying as much as $80,000 for the exact same drug they use now for a fraction of the cost, if not gratis.

I can think of no possible reason, no public good that comes from taking a drug that was easily available and working exactly as it should and have someone suddenly be able to charge $80,000 a year for it. This is not a reward for innovation or risk-taking -- this is exploitation of a regulatory loophole, a blatant shakedown, or so it seems to me.

Retrophin hasn't done any new trials, and they haven't had to. They've just bought someone else's old drug that they believed could be sold for twenty times its price, and have put that plan right into action. No development costs, no risks whatsoever -- just slap a new sticker on it and put your hands over your ears. This is exactly the sort of thing that makes people go into fist-clenching rages about the drug industry, and with damn good reason. This one enrages me, and I do drug research for a living.

He's probably not alone in being enraged, but this kind of abuse is so lucrative for the companies prepared to take this route that we're probably going to see more of it until this particular loophole is closed.

The campaign will fund a xenograft experiment, which is the next step in developing the promising anti-cancer compound "9DS". This experiment needs to be completed before 9DS can move on to clinical trials.

Here are some more details of both the drug and the project:

The drug candidate 9DS was developed at the University of Maryland. The last work done on the drug showed that it had activity against cancer competitive with leading cancer drugs such as taxol. Moreover, 9DS is also likely to have lower side effects than most chemotherapies, since a related compound, SJG-136, seems to have low side effects in early clinical trials.

Project Marilyn involves: production of more 9DS, and submitting 9DS to a xenograft study ('curing cancer in mice'). This is the next step in drug development and an important one on the way to doing clinical (human) studies. The process we're seeking to fund should take approximately 6 months. If we receive more funding, we will add stretch goals, such as further preclinical experiments on 9DS, development 9DS analogs, or other exciting anti-cancer ideas.

Provided that the xenograft study goes well, 9DS will move into further preclinical trials, possibly through a collaboration with a for-profit company. Research and development at the later stages costs between $1 million and $10 million and will likely not be crowdfunded.

Due the drug's patent status, the threat of competition is likely to keep the price of 9DS low, regardless of a partnership with a for-profit company. Currently, when a drug loses its patent status, the price can come down ten-fold, according to [project leader Dr. Isaac] Yonemoto.

It's only a small-scale project, but it's exciting to see new funding models being tried out for drug development. Moreover, the Times of San Diego reports that Yonemoto wants his site indysci.org to host further crowdfunded projects, both from himself and other researchers. Let's hope enough pledges are made, and that others do indeed start to build on the idea.

from the and-what-about-all-those-overpayments? dept

For some time now, Techdirt has been following the "pay for delay" scandal, whereby a big pharma company buys off manufacturers of generics so that the former can continue to enjoy monopoly pricing long after its patents have expired. As we've reported, the authorities have finally started to clamp down on this abuse of the patent system. At the end of last year, two drug companies were fined by the European Commission, and now it looks like the FTC wants to follow suit, as the Wall Street Journal reports:

For the first time since the U.S. Supreme Court ruled last year that so-called pay-to-delay deals may be subject to greater antitrust scrutiny, the U.S. Federal Trade Commission has filed a lawsuit charging drug makers with violating anti-trust laws and hurting consumers in their collective pocketbooks.

Specifically, the agency charged several drug makers -- including AbbVie, Abbott Laboratories, which spun off AbbVie, and Teva Pharmaceuticals -- for striking deals that delayed the availability of the widely promoted AndroGel testosterone replacement therapy, a $1 billion seller.

The article includes some details on how the "pay for delay" deals worked:

In its lawsuit, the FTC charges that AbbVie, Abbott and Bevins Healthcare filed “sham” patent litigation against potential generic rivals, including Teva, and then entered into an allegedly illegal patent settlement in order to thwart competition.

Although it's great that the FTC is finally tackling this problem, it's regrettable that it had to wait so long for that ruling by the Supreme Court (pdf) to give it the legal basis for pursuing pharma companies:

The FTC had spent years trying to convince Congress and the courts that pay-to-delay deals hurt the economy. The agency, in fact, regularly released reports estimating the deals cost consumers dearly. In the last such report, which was issued in early 2013, the agency estimated the deals cost Americans $3.5 billion annually and contributed to the federal deficit.

The delay in bringing these cases doubtless means that the companies engaging in this behavior have made some serious profits as a result -- and that the public has been forced to pay billions of dollars unnecessarily.

from the back-burner dept

As you may have heard, there's been a somewhat scary Ebola outbreak in western Africa. You may have also heard about what some are calling a "secret miracle serum" that effectively stops the impact of the virus for those who catch it. It's an experimental drug that hasn't undergone human clinical trials yet, but it was apparently given to a couple of Americans and appears to be working. There's some indication that it would take a couple months to produce a larger number of doses -- though, again, the lack of testing here means that people really aren't sure if it will work (or if there are serious side effects).

“These outbreaks affect the poorest communities on the planet. Although they do create incredible upheaval, they are relatively rare events,” said Daniel Bausch, a medical researcher in the US who works on Ebola and other infectious diseases.

“So if you look at the interest of pharmaceutical companies, there is not huge enthusiasm to take an Ebola drug through phase one, two, and three of a trial and make an Ebola vaccine that maybe a few tens of thousands or hundreds of thousands of people will use.”

While some may question whether or not Bausch's statement is just from frustration from where he is, Big Pharma execs more or less confirm his claims. Remember that it was just a few months ago that we wrote about Bayer's CEO claiming directly that they make drugs for rich people who can afford it:

"We did not develop this medicine for Indians," Dekkers said Dec. 3. "We developed it for western patients who can afford it."

As we noted at the time, it's worth comparing that statement to what George Merck, the former President of Merck said many decades ago concerning the pharma industry:

We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.